MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-30 for GUIDEZILLA II 1873 manufactured by Boston Scientific Corporation.
[185664867]
(b)(6). Device evaluated by mfr: the device was returned for analysis. Returned product consisted of a guidezilla guide extension catheter. Analysis of the tip, distal shaft, collar, and hypotube included microscopic and visual inspection. Inspection revealed tip damage (misshapen), shaft damage (abrasions), and the collar/shaft area had a partial separation. Inspection of the rest of the device found no other damage or defects. When the guidezilla was removed from the biohazard bag, the device was bent in the collar/distal shaft partial separation area, as if kinked. No other issues were identified during the product analysis.
Patient Sequence No: 1, Text Type: N, H10
[185664868]
Reportable based on device analysis completed on 10mar2020. It was reported that the guidezilla became kinked. A guidezilla guide extension catheter was selected for use. During the procedure, it was noted that the guidezilla became kinked. The procedure was completed with a different device. No patient complications were reported. However, device analysis revealed that the collar/shaft area had a partial separation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03982 |
| MDR Report Key | 9897146 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-07-26 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | BOSTON SCIENTIFIC SCIMED, INC |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55311 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GUIDEZILLA II |
| Generic Name | CATHETER, PERCUTANEOUS |
| Product Code | DQY |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-02-15 |
| Model Number | 1873 |
| Catalog Number | 1873 |
| Lot Number | 0024171661 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |